Menopause Clinical Trial
Official title:
Randomized, Double-Blind, Plac.-Controlled Clinical Study to Compare the Efficacy of FP-101 60mg b.i.d. vs. Placebo for the Treatment of Moderate-to-Severe Hot Flashes in Peri- and Post-menopausal Women Over a Period of 1-Week.
Verified date | October 2023 |
Source | Fervent Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.
Status | Completed |
Enrollment | 105 |
Est. completion date | July 31, 2023 |
Est. primary completion date | April 5, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 46 Years and older |
Eligibility | Inclusion Criteria: - Peri- and Post-Menopausal female subjects (>45 yrs) experiencing a min of 7-8 moderate to severe hot flashes per day - Able/willing to provide informed consent. - Able/willing to complete all study procedures and visits. - Able/willing to not use any over-the-counter (OTC) cough & cold medications that contain the IMP active during the study. Exclusion Criteria: - Subject exhibits positive home pregnancy test at screening or any time during study - Subject currently taking any form of Hormone Therapy (HT), including local estrogen therapies - Subject currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy. - Subject with history of serotonergic syndrome - Subject is currently taking monoamine oxidase inhibitors (MAOIs) (or for 2 weeks after stopping the MAOI drug), antidepressants, thioridazine, pimozide, cannabidiol, opioids, antipsychotic agents, antiretroviral agents, quinidine, quinine, or other medications for VMS such as BrisdelleĀ® (paroxetine mesylate), clonidine and gabapentin. - Subject is currently taking a dietary/herbal supplement(s) to manage VMS, such as soy isoflavones or black cohosh. - Subject has uncontrolled diabetes, a history of hypertension & is not on a stable dose of antihypertensive medications for at least 30 days prior to screening. - Subject has clinically unstable cardiac disease, including atrial fibrillation, symptomatic brady- or tachy-arrhythmias, congestive heart failure (NYHA class II, III, and IV), or symptomatic atherosclerotic cardiovascular disease (coronary artery disease, carotid artery disease or peripheral artery disease) or history of myocardial infarction or stroke within 2 years of enrolment in the study. - Subject reports medical history suggestive of impaired liver/kidney function or, in the PI's opinion, exhibits liver/kidney function impairment to the extent that the subject should not participate in the study. - Subject has biliary tract disease, adrenal cortical insufficiency, or any other medical condition that, in the PI's opinion (and after discussion with the medical monitor), is considered inadequately treated and precludes entry into the study. - Subject has thyroid disease, unless subject is clinically stable with normal thyroid indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine) for =6 months prior to screening. - Subject has a history of, or is currently presenting with, substance use disorder as defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Subject has a history of psychiatric disorders, including a lifetime history of major depressive disorder, bipolar disorder, panic disorder, generalized anxiety, psychotic disorders, suicidality or suicidal ideation, or post-traumatic stress disorder. - Subject is currently participating in another clinical trial - Subjects who were determined to be placebo responders or non-compliant during the 1-week run-in period. |
Country | Name | City | State |
---|---|---|---|
United States | Cary Medical Group | Cary | North Carolina |
United States | Inpatient Research Clinic | Hialeah | Florida |
United States | Torrance Clinical Research Institute | Lomita | California |
United States | Long Beach Clinical Trial Services | Long Beach | California |
United States | The Angel Medical Research Corporation | Miami Lakes | Florida |
United States | Suncoast Clinical Research - Pasco County | New Port Richey | Florida |
United States | Coastal Carolina Research Center | North Charleston | South Carolina |
United States | Clinical Research of Philadelphia | Philadelphia | Pennsylvania |
United States | Raleigh Medical Group | Raleigh | North Carolina |
United States | Discovery Clinical Trials - Stone Oak | San Antonio | Texas |
United States | ICON Early Phase Services | San Antonio | Texas |
United States | Provideré Research Inc. | West Covina | California |
Lead Sponsor | Collaborator |
---|---|
Fervent Pharmaceuticals | ICON plc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Any Adverse Events and Concomitant Medications | Subjects will use daily eDiary to record any AEs and concomitant medications | Recorded as needed/every 12 hrs over a 1-week treatment period. | |
Primary | Change in the frequency (average daily number) of moderate-to-severe hot flashes. | Subjects use a digital platform to record hot flash frequency in a daily eDiary. | Recorded every 12 hrs over a 1-week treatment period. | |
Secondary | Change in the severity (average daily rating) of moderate-to-severe hot flashes. | Subjects use digital platform to record hot flash severity (3-point scale) in a daily eDiary. | Recorded every 12 hrs over a 1-week treatment period. | |
Secondary | Change in nighttime awakenings (average daily number) with or without night sweats. | Subjects use daily eDiary to record nighttime awakenings & night sweats frequency. | Recorded every morning over a 1-week treatment period. | |
Secondary | Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment. | Completing validated Patient Global Improvement Scale (7-point) with PI. | After 1 week of treatment at the end-of-study visit. |
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